Bharat Biotech, which had requested DCGI’s recommendation on the conduct of phase 3 clinical trials of its COVID-19 candidate vaccine, requested to submit comprehensive knowledge on the protection and immunogenicity of the ongoing Phase 2 trial, in addition to providing some clarification, before moving on to the next step.
The vaccine candidate, “Covaxin”, is developed through Bharat Biotech in collaboration with the Medical Research Council of India (ICMR).
According to officials, Hyderabad-based vaccine manufacturer filed an application with the Indian Drug Comptroller-General (DCGI) on 2 October, requesting permission for a randomized, double-blind, placebo-controlled multicenter trial of its COVID-19 candidate vaccine.
The firm’s request said the canopy would cover 28,500 subjects over the age of 18 and be held at 19 sites, including Delhi, Mumbai, Patna and Lucknow, in 10 states.
According to sources, Covaxin Phase 2 trial is underway and the dose has still been administered to volunteers at some sites.
“The company presented the Protocol for Phase 3 clinical trials as an intermediate knowledge of phase 1 and 2 clinical trials,” one official said.
The Committee of Experts on The Subject (SEC) of the Central Organization for the Control of Pharmaceutical Standards (CDSCO) discussed the application on October 5.
“After careful deliberation, the Committee found that the design of Phase 3 was initially satisfactory, with the exception of an explanation of the definition of asymptomatic, etc.
“However, the test should be initiated at an appropriate dose known from knowledge of immunogenicity and phase 2 protection. As a result, the company will need to present knowledge of immunogenicity and protection of the Phase 2 trial for review,” the panel said in its recommendations.
During its discussion, the SEC also noted that the vaccine was well tolerated in all dose equipment and that no serious adverse occasions have been reported to date, one source said.
The maximum non-unusual adverse pain at the injection site, which was transiently resolved, the source said.
The application of 3 clinical trials proposed a dose of 0. 5 ml on days 0 and 28, Resources said.
In addition, Bharat Biotech, a candidate vaccine developed through Zydus Cadila Ltd, is found in phase 2 human clinical trials.
The Pune-based Indian Serum Institute, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate, is conducting phase 2 and 3 human clinical trials with the candidate in India.
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